NCT03675698

Brief Summary

This trial is planned to estimate the size of nasotracheal tube (NTT) by calculating the diameter of both nasal cavity in radiological images of nose (CT scan/MRI) at the level below the inferior turbinate and floor of nose in coronal planes. Smallest diameter will be considered to calculate the outer diameter of NTT, hence the size .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 18, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

October 25, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2020

Completed
Last Updated

June 17, 2020

Status Verified

June 1, 2020

Enrollment Period

12 months

First QC Date

September 15, 2018

Last Update Submit

June 16, 2020

Conditions

Keywords

Nasotracheal tube size based on radiological images of nose.

Outcome Measures

Primary Outcomes (1)

  • Successful nasal intubation by selecting the correct size of nasotracheal tube estimated by measuring the diameter of nasal cavity in coronal section just below the inferior turbinate in radiological images.

    The diameter of both nasal cavities in coronal section of CT/MRI will be calculated at the level just below the inferior turbinate in anterior nasal cavity when inferior turbinates just appeared in the radiological image, than at level of maxillary sinus and just before cohanal opening in radiological images. Minimal diameter will be used to estimate the size of nasotracheal tube before intubation.The images will also be used to select the side of nasal intubation after ruling out any nasal pathology like DNS, Spurs and marked turbinate hypretrophy.

    After enrolment of the patient and before intubation

Secondary Outcomes (1)

  • To find the complications associated with nasal intubations that were performed after assessing the radiological images.

    At the time of intubation

Interventions

side of nostril and size of endotracheal tube estimation for nasotracheal intubation will be done based on radiological imaging ( CT/MRI head)

Also known as: Malinckrodt flexometallic tube

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

oncosurgical patients with oral malignancies who required nasotracheal intubation for COMMANDO surgeries.

You may qualify if:

  • patients requiring nasal intubation for oromaxillofacial surgeries

You may not qualify if:

  • \. Midface instability
  • Coagulopathy
  • Suspected basilar skull fractures
  • Large nasal polyps
  • Suspected nasal foreign bodies
  • Recent nasal surgery
  • History of frequent episodes of epistaxis
  • Prosthetic heart valves (increased risk of bacteremia during the insertion).
  • Patients with deranged liver and renal functions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amit

Rohini, National Capital Territory of Delhi, 110085, India

Location

Related Publications (1)

  • Evans SW, McCahon RA. Management of the airway in maxillofacial surgery: part 2. Br J Oral Maxillofac Surg. 2018 Jul;56(6):469-474. doi: 10.1016/j.bjoms.2018.05.012. Epub 2018 Jun 12.

    PMID: 29907468BACKGROUND

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant in-charge

Study Record Dates

First Submitted

September 15, 2018

First Posted

September 18, 2018

Study Start

October 25, 2018

Primary Completion

October 24, 2019

Study Completion

March 10, 2020

Last Updated

June 17, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations